Pivotal Study of the Rx Al-Sense Liner for Amniotic Fluid Leakage Screening
Completed · Not applicable
Conditions studied: Amniotic Problems
In brief
This is a Prospective open-label, comparative pivotal study with comparison of self-assessments with blinded investigator assessments. Pregnant women attending the labor and delivery unit of the hospital or emergency clinic and reporting unidentified wetness (undetermined whether this is amniotic fluid leakage or urinary incontinence) will be enrolled in this study. After informed consent is obtained, each subject will be given a single AL-SENSE to use up to 12 hours or until the perception of wetness. Product Usage After usage, the subject will read and record any occurrence of color change of the AL-SENSE 10 minutes after the liner removal and to mark if it changes color to blue or to green or not on the designated form. The subjects will fill out the questionnaire regarding the product usage experience and the liner color reading with no help from the investigator, to validate IFU reading comprehension. A blinded clinician will perform a "standard clinical diagnosis" (clinical assessment). The standard clinical diagnostic methods will include the following tests: (1) Pooling test, (2) Ferning test, (3) pH test by pH paper. A positive Pooling test and/or positive results in both the pH test and the Ferning test will be defined as a positive clinical test result.
Key facts
- Study ID
- NCT02959268
- Run by
- Common Sense
- People needed
- 250
- Starts
- 2016-11-01
- Expected to finish
- 2017-10-01
- Last updated by the study team
- 2019-10-31
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Screening/ Baseline inclusion criteria for subject participation in the study at baseline assessment are pregnant women age 18 and above who have completed minimum 16 weeks of pregnancy are eligible for the study. Subject attending the labor and delivery unit of the hospital or emergency clinic or outpatient clinic and reporting a feeling of vaginal wetness feeling (undetermined whether this is amniotic fluid leakage or urinary incontinence)
Where it is running
- Jersey Shore University Medical Center — Neptune City, New Jersey, United States
- Rutgers Womens Health Institute — New Brunswick, New Jersey, United States
- University Hospital Rutgers Newark — Newark, New Jersey, United States
- Drexel University Medical School — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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